Pharmacokinetic variables
| Variable (mean ± S.D.) | N-PP4-a | N-D | N-D | N-D | P4-b |
|---|---|---|---|---|---|
| Injection site | Gluteal | Gluteal | Gluteal | Deltoid | |
| Injection volume (ml) | 4 | 4 | 1 | 1 | |
| Dose (mg) | 100 | 100 | 100 | 100 | |
| Number of patients | 7 | 6 | 5 | 5 | |
| Time of peak (days) | |||||
| Empirical | 1.0 ± 0.9 | 5.0 ± 3.2 | 2.4 ± 1.5 | 3.6 ± 2.3 | .022 |
| Fitted | 1.1 ± 0.1 | 1.8 ± 0.3 | 1.6 ± 0.2 | 1.5 ± 0.2 | <.001 |
| Peak concentration (nM) | |||||
| Empirical | 30.9 ± 5.8 | 13.5 ± 5.0 | 15.8 ± 2.8 | 12.4 ± 5.5 | <.001 |
| Fitted | 32.5 ± 2.5 | 12.7 ± 1.1 | 16.1 ± 1.0 | 8.4 ± 0.5 | <.001 |
| Mean residence time (days) | |||||
| Empirical | 4.5 ± 0.7 | 10.1 ± 1.5 | 10.0 ± 1.2 | 11.4 ± 1.1 | <.001 |
| Fitted | 3.1 ± 0.2 | 9.5 ± 0.7 | 10.6 ± 0.9 | 16.9 ± 1.3 | <.001 |
| Half-time (days) | |||||
| Absorption | 2.4 ± 0.1 | 7.0 ± 0.4 | 7.7 ± 0.6 | 12.0 ± 0.9 | <.001 |
| Clearance | 0.25 ± 0.05 | 0.42 ± 0.11 | 0.34 ± 0.06 | 0.25 ± 0.05 | .002 |
| Duration ≥5 nM (days) | 5.1 ± 2.0 | 9.4 ± 1.1 | 13.3 ± 2.9 | 9.0 ± 5.1 | .002 |
| Clearance (liters/day) | 1359 ± 149 | 1355 ± 95 | 1041 ± 59 | 1421 ± 57 | <.001 |
| Area under the curve (nmol · day/liter) | |||||
| Empirical | 155 ± 21 | 144 ± 30 | 193 ± 29 | 162 ± 34 | .065 |
| Fitted | 181 ± 20 | 172 ± 12 | 224 ± 13 | 164 ± 7 | <.001 |